3
Indication details
- Combined Agent(s)
- Nivolumab
- Control Arm
- Nivolumab
- FDA Therapeutic Indication
- First line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression <1%.
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- PD-L1 expression <1%
- Trial Name
- RELATIVITY-047
- NCT Number
- NCT03470922
- Trial Phase
- Phase II/III
Approval details
- EMA Approval
- EMA (CHMP) July 2022 EC decision September 2022
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 2.9 months
- PFS Gain
- 3.5 months
- PFS HR
- 0.66 (0.51-0.84)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
EMA (CHMP) July 2022 EC decision September 2022
The long-term benefit seems promising and the melanoma paradigm suggests that the experimental curve will likely plateau. A longer follow-up would confirm whether this study is eligible for a final score of 4 based on a plateau bonus (>10% improvement at 2-years).
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 366
- Scorecard version
- 1
- Issue date
- 11.01.2023
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.